Pefloxacin is indicated in adults for the treatment of single or mixed infections caused by one or more susceptible microorganisms. It may also be used in infections caused by organisms that are resistant to other antibiotics.

Pefloxacin is indicated for the following conditions:

• Gastrointestinal infections: Enteric fever, acute bacterial diarrhoea, and chronic Salmonella carriage.
• Urinary tract infections: Cystitis, pyelonephritis, prostatitis, epididymitis, and uncomplicated or complicated urethritis.
• Respiratory tract infections: Pneumonia, acute and chronic bronchitis, cystic fibrosis, bronchiectasis, and empyema.
• Ear, nose, and throat infections: Otitis media, otitis externa, sinusitis, and tonsillitis.
• Bone and joint infections: Osteomyelitis and arthritis.
• Skin and soft tissue infections: Infected ulcers, wound infections, abscess, cellulitis, erysipelas, and infected burns.
• Pelvic infections: Salpingitis, endometritis, and pelviperitonitis.
• Abdominal and hepatobiliary infections: Peritonitis, intra-abdominal abscess, cholangitis, cholecystitis, and empyema of the gallbladder.

Pefloxacin is also used in septicaemia, bacteraemia, gonorrhoea, endocarditis, and meningitis.

Pefloxacin is a synthetic antibacterial agent belonging to the fluoroquinolone group. It acts by inhibiting the A subunit of DNA gyrase (topoisomerase II), an essential enzyme involved in bacterial DNA replication. Pefloxacin has bactericidal activity and exhibits a broad spectrum of antibacterial action.

Adults with normal hepatic function: The usual dose of pefloxacin 400 mg tablet is one tablet every 12 hours (morning and evening), preferably taken with meals to reduce gastrointestinal discomfort. An initial loading dose of 800 mg may be administered to achieve effective blood concentrations more rapidly.

Adults with hepatic insufficiency: In patients with severe hepatic impairment or reduced hepatic blood flow, the dosage should be adjusted by increasing the interval between doses. Dose reduction is generally not required in renal insufficiency.

Duration of treatment:

• Treatment is usually continued for 5 to 10 days.
• Specific treatment durations: Chronic prostatitis, cystic fibrosis, and chronic Salmonella carriers: 14 days
• Endocarditis: up to 6 months
• Chronic osteomyelitis: up to 1 year
• Gonorrhoea: 2 tablets as a single dose

Concomitant administration of pefloxacin with antacids containing aluminium hydroxide and/or magnesium hydroxide gel may reduce the absorption of pefloxacin. Therefore, the concurrent use of these agents with pefloxacin should be avoided.

Pefloxacin is contraindicated in patients with known hypersensitivity to pefloxacin or other quinolone antibiotics. It is also contraindicated in children under 15 years of age, pregnant and lactating women, patients with inherited glucose-6-phosphate dehydrogenase (G6PD) deficiency, and those with a history of tendon disorders, including tendinitis or tendon rupture.

Occasionally reported adverse effects of pefloxacin include the following- Gastrointestinal disturbances: Epigastric pain, nausea, vomiting, diarrhoea, and dyspepsia. Central nervous system disturbances: Headache and insomnia. Hypersensitivity reactions: Skin rash, pruritus, and photosensitization. Other adverse effects: Myalgia and/or arthralgia, tendinitis, and rupture of the Achilles tendon.

Pefloxacin has been classified as Pregnancy Category C by the US FDA.

Because of the risk of photosensitivity reactions, patients should avoid exposure to sunlight and ultraviolet (UV) radiation during treatment with pefloxacin. Dosage adjustment is required in patients with severe hepatic insufficiency. Patients should also be advised about the possibility of pain in the Achilles tendon, which may indicate tendon injury.

4-Quinolone preparations

Store below 30°C, protected from light and moisture. Keep out of the reach of children.